Alexza’s Technology Foundation
The heart of the hand-held Staccato® system is a heat package with a stainless steel substrate, onto which a thin film of unformulated drug is coated. When the patient draws a normal breath through the Staccato system, the substrate surface instantaneously heats to create a condensation aerosol. The patient inhales perfectly sized particles of pure drug down into the narrower, more vascularized tissue of the deep lung, allowing fast and more complete absorption into the bloodstream.
We believe our Staccato system matches the delivery characteristics and product attributes to patient needs for acute and intermittent conditions, and also has the following advantages:
The aerosol produced with the Staccato system is designed to be rapidly absorbed through the deep lung with a speed of therapeutic onset comparable to an IV injection, generally achieving peak plasma levels of drug in two to five minutes.
Ease of Use
The Staccato system is breath actuated, and a patient simply inhales to administer the drug dose. Unlike injections, the Staccato system is noninvasive and does not require caregiver assistance. The aerosol produced with the Staccato system is relatively insensitive to patient inhalation rates. Unlike many other inhalation technologies, the patient does not need to learn a special breathing pattern. In addition, the Staccato device is small and easily portable.
Consistent Particle Size and Dose
The Staccato system uses rapid heating of the drug film to create consistent and appropriate particle sizes for deep lung inhalation and absorption into the bloodstream. The Staccato system also produces a consistent high emitted dose, regardless of the patient’s breathing pattern. Studies have shown that devices employing the Staccato system emit >90% of the loaded drug as a small particle size aerosol, characterized by an aerosol mass median aerodynamic diameter (MMAD) of between 1µm and 3µm.
We have screened over 400 drugs, and approximately 200 have exhibited initial vaporization feasibility using the Staccato system. The Staccato system can deliver both water soluble and water insoluble drugs and eliminates the need for excipients and additives such as detergents, stabilizers and solvents, avoiding side effects that may be associated with the excipient or additives.
The Staccato system can incorporate lockout and multiple dose features, potentially enhancing safety, convenience of patient titration and a variety of administration regimens.
Currently we have six development programs underway and, as we look beyond these programs, we are optimistic that our proprietary technology will support a wide array of new therapies targeting acute and intermittent conditions.
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